Long-Term Results of the Linear Incision Technique With Tissue Reduction Versus Tissue Preservation for Inserting Bone-Anchored Hearing Implants: The Ongoing Optimization in Bone Implant Surgery.

OBJECTIVE: To compare the long-term outcomes of the linear incision technique with tissue reduction (LIT-TR) and the linear incision technique with tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs). STUDY DESIGN: Single-center retrospective cohort study. SETTING: Large general teaching hospital. PATIENTS: A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. INTERVENTION: The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). MAIN OUTCOME MEASURES: Soft tissue reactions, skin thickening, postoperative complications (e.g., wound dehiscence), and implant loss were compared between the test and control group. Furthermore, Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden) and Oticon Medical AB (Askim, Sweden) implants/abutments within the LIT-TP cohort were compared. Validated questionnaires were used to quantify patients' health-related quality of life (HRQoL). RESULTS: Significantly more cases with wound dehiscence and adverse soft tissue reactions (Holgers ≥2) were observed in the LIT-TR cohort (p < 0.001). However, the LIT-TP cohort showed significantly more cases with skin thickening (requiring treatment) within the first 2 years after implantation. There were no differences in implant loss rates, overall soft tissue reactions (Holgers >1), and overall HRQoL between the two patient groups. Significant improvement in the patients' HRQoL after implementation of a BAHI was found in both techniques. The Ponto Wide implant/abutment showed less frequent skin thickening (requiring treatment) and fewer soft tissue reactions compared with the BIA400 implant/abutment. CONCLUSION: This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

Stumbling Blocks in the Investigation of the Relationship Between Age-Related Hearing Loss and Cognitive Impairment.

The relationship between age-related hearing loss (ARHL) and cognitive impairment (CI) remains intricate. However, there is no robust evidence from experimental or clinical studies to elucidate their relationship. The key unaddressed questions are (a) whether there is a causal effect of ARHL on CI and (b) whether efficacious treatment of ARHL (such as hearing-aid use) ameliorates CI and dementia-related behavioral symptoms. Because of several methodological and systematic flaws/challenges, rigorous verification has not been conducted. Addressing these stumbling blocks is essential to unraveling the relationship between ARHL and CI, which motivated us to undertake this review. Here, we discuss the methodological problems from the perspectives of potential confounding bias, assessments of CI and ARHL, hearing-aid use, functional-imaging studies, and animal models based on the latest information and our experiences. We also identify potential solutions for each problem from the viewpoints of clinical epidemiology. We believe that "objectivity," specifically the use of more objective behavioral assessments and new computerized technologies, may be the key to improving experimental designs for studying the relationship between ARHL and CI.

Percutaneous Bone-Anchored Hearing Implant Surgery: Do Syndromic Children Have More Adverse Perioperative Outcomes?

OBJECTIVE: To evaluate and compare perioperative outcomes of percutaneous bone-anchored hearing implant (BAHI) surgery in syndromic and nonsyndromic pediatric patients. STUDY DESIGN: Retrospective cohort study. SETTING: McGill University Health Centre in Montreal, Quebec, Canada. PATIENTS: Forty-one pediatric patients (22 syndromic, 19 nonsyndromic) who underwent percutaneous BAHI surgery between March 2008 and April 2021. INTERVENTION: Percutaneous BAHI surgery. MAIN OUTCOME MEASURES: Patient demographics (age at surgery, gender, implant laterality), operative information (American Society of Anesthesia [ASA] score, anesthesia type, surgical technique, implant/abutment characteristics), and postoperative outcomes (implant stability, soft tissue integrity, surgical revisions, implant failure). RESULTS: The most frequent syndromes among implanted patients were Treacher Collins (27.3%), Goldenhar (13.6%), Trisomy 21 (13.6%), and Nager (9.1%). Syndromic patients were more frequently given higher ASA scores: 2 ( p = 0.003) and 3 ( p = 0.014). All cases of implant extrusion were in syndromic patients: two posttraumatic and two failures to osseointegrate. Nine (40.9%) syndromic patients experienced a Holgers Grade 4 skin reaction at one of their postoperative follow-up visits as compared to 0% of nonsyndromic patients ( p < 0.001). Implant stability was similar between cohorts at all postoperative time-points, except for significantly greater nonsyndromic implant stability quotient scores at 16 weeks ( p = 0.027) and 31+ weeks ( p = 0.016). CONCLUSIONS: Percutaneous BAHI surgery is a successful rehabilitation option in syndromic patients. However, it presents a relatively higher incidence of implant extrusion and severe postoperative skin reactions as compared to nonsyndromic patients. In light of these findings, syndromic patients may be great candidates for novel transcutaneous bone conduction implants.

Ações socioeducativas em saúde auditiva para jovens utilizando educação híbrida / Social-educational hearing health activities based on blended learning / Actividades socioeducativas en salud auditiva basadas en la educación híbr

Introdução: O uso frequente de música amplificada pelos jovens traz a reflexão da importância de projetos de promoção de saúde auditiva, visando a conscientização dos jovens e mudança de comportamento. Objetivo: promover o aprendizado sobre o tema, avaliar o conhecimento sobre saúde auditiva e multiplicar o conhecimento adquirido junto à comunidade. Métodos: foi realizado uma ação socioeducativa em saúde auditiva com 12 alunos do sétimo ano do Ensino Fundamental II de uma Escola Publica no Sudeste do Brasil. A ação foi organizada com base em educação híbrida (encontros presenciais e uso do AIA), utilizando a metodologia do Projeto Jovem Doutor. Para a avaliação, os alunos responderam a um questionário sobre conhecimento prévio, comportamento auditivo e um questionário situação-problema. O AIA foi avaliado por meio da Ficha de Pesquisa Motivacional, foi realizada a análise do Impacto através de um questionário para os professores. Resultados: observou-se que houve mudança no comportamento dos alunos no que diz respeito ao tempo de uso e volume dos fones de ouvido, verificou-se que 100% melhoraram seu conhecimento sobre os riscos de altas intensidades sonoras para a audição. Ao avaliarmos o AIA, a análise descritiva evidenciou que os valores da média de melhor desempenho foram para as dimensões organizado e fácil de usar. Na última etapa, 802 pessoas foram envolvidas, nas atividades interativas em sala de aula e nos Espaços Culturais em saúde auditiva, criando uma cadeia produtiva em saúde. Conclusão: Por meio desta ação, foi possível atingir diretamente os jovens, promovendo o aprendizado, mudança de comportamento e melhora na qualidade de vida desses jovens. (AU)

Introduction: young people often listen to amplified music, which calls attention to the importance of projects to promote their hearing health, raise their awareness, and change their behaviors. Objective:to promote learning on the topic, assess knowledge on hearing health, and spread acquired knowledge to the community. Methods: a hearing health social-educational program was carried out with 12 seventh graders at a public school in Southeastern Brazil. The program was organized for blended learning (in-person meetings and virtual learning environment [VLE] activities), using the Young Doctor Project methodology. For the assessment, students answered a questionnaire on their previous knowledge and auditory behavior, as well as a problem-situation questionnaire. VLE was assessed with a motivational survey sheet, and the impact of the program was analyzed through a questionnaire administered to the teachers. Results: there were changes in the students' behaviors regarding the time and volume at which they used the earphones. Also, 100% of them improved their knowledge of the risks high sound levels pose to hearing. The VLE descriptive analysis indicated that the mean values of the "organized" and "easy to use" domains had the best performances. The last stage involved 802 people in the classroom interactive activities and hearing health cultural spaces, which created a health production chain.Conclusion: the program directly reached young people, promoting their learning, behavior changes, and improved quality of life. (AU)

Introducción: El uso frecuente de música amplificada por parte de los jóvenes, trae la reflexión sobre la importancia de los proyectos de promoción de la salud auditiva, orientados a la sensibilización de los jóvenes y al cambio de comportamiento. Objetivo: promover el aprendizaje sobre el tema de la salud auditiva, evaluar conocimientos y multiplicar los conocimientos adquiridos en la comunidade. Métodos: una acción socioeducativa en salud auditiva con 12 alumnos del séptimo año de la Escuela Primaria II de una escuela pública del sudeste de Brasil. La acción se organizó y basó en la educación híbrida (encuentros presenciales y uso del entorno de aprendizaje interactivo), utilizando la metodología del Proyecto Doctor Joven. Para la evaluación, los estudiantes respondieron un cuestionario sobre conocimientos previos, comportamiento auditivo y un cuestionario de situación problema. La entorno de aprendizaje interactivo se evaluó mediante el Formulario de Investigación Motivacional, el análisis de Impacto se realizó en un cuestionario para docentes. Resultados: se observó que hubo un cambio en el comportamiento de los estudiantes con respecto al tiempo de uso y volumen del audífono, se encontró que el 100% mejoró sus conocimientos sobre los riesgos de alta intensidad sonora para audiencia. Al evaluar el entorno de aprendizaje interactivo, el análisis descriptivo mostró que los valores del promedio de mejor desempeño fueron para las dimensiones organizadas y fáciles de usar. Durante la etapa final, 802 personas se involucraron en actividades interactivas en el aula y en los Espacios Culturales en salud auditiva, creando una cadena productiva en salud. Conclusión: A través de esta acción se logró llegar directamente a los jóvenes, promoviendo el aprendizaje, el cambio de comportamiento y mejorando la calidad de vida de estos jóvenes. (AU)

Deaf children with additional disabilities (AD+): CODEPEH recommendations.

Approximately 40% of children with deafness have an additional developmental disorder or major medical problem, which may delay the age of diagnosis of hearing loss and/or require intervention by other professionals. This situation is referred to as "deafness with added disability" (AD+). The reason why the population of hearing-impaired children is more likely to have associated added disabilities is that the risk factors for hearing impairment overlap with those for many other disabilities. These factors can influence various aspects of development, including language acquisition. It is important to check that appropriate care is received, the effectiveness of hearing aids or implants, as well speech therapy intervention strategies, and family adherence to sessions and appointments. The challenge posed by AD+ is early detection, to allow early and appropriate intervention, and the need for fluid transdisciplinary collaboration between all professionals involved, together with the involvement of the family.

Protecting cognitive function in older adults with age-related hearing loss: Insights from The Irish Longitudinal Study on Ageing (TILDA) and the role of hearing aids.

BACKGROUND: Age-related hearing loss (ARHL) is prevalent in adults over 70, impairing hearing sensitivity and speech perception. ARHL has been linked to an increased risk of cognitive decline and dementia. However, most affected adults are not receiving adequate treatment, including hearing aids. OBJECTIVE: This study aimed to evaluate the impact of ARHL on cognitive decline in older adults participating in the Irish Longitudinal Study on Aging (TILDA). DESIGN: METHODS: Data from four TILDA waves, a 6-year follow-up, was collected and analyzed using zero-inflated Poisson regression. The primary outcome, cognitive function, was assessed using Mini-Mental State Examination (MMSE) total score and error counts. RESULTS: Our analysis revealed that age, education, use of aids to help with hearing, and history of stroke were significantly associated with error counts at baseline. Additionally, poor hearing was associated with a negative change in MMSE score from wave 4, indicating the potential role of ARHL in cognitive decline. When further adjusted for age, sex, history of stroke, hypertension, any emotional, nervous, or psychiatric problem, polypharmacy, and hearing aids, the zero-inflated Poisson model indicated that poor hearing, use of hearing aids, stroke, hypertension, and polypharmacy all predicted MMSE error counts in follow-up assessments. Moreover, the use of hearing aids was associated with a decreased likelihood of cognitive decline. CONCLUSION: ARHL was independently associated with cognitive decline, underscoring the importance of addressing hearing loss in older adults. Future research should explore the potential of hearing aids to protect cognitive functioning in older adults.

Skin and soft tissue complications of bone-anchored hearing aids: Introducing a new classification system.

OBJECTIVES: There have been significant surgical and technological advances in bone-anchored hearing aid (BAHA) design, function, and implantation technique, but peri-implant skin complications remain the most frequent complication. The most important aspect in dealing with cutaneous complications is to identify the type of cutaneous lesion. Although Holger's Classification has been an extremely useful clinical tool, this grading system has been shown to be unsuitable for some cases. We therefore propose a new consistent and easy assessment classification of cutaneous complications associated with BAHA. METHODS: A retrospective clinical study was carried out at a tertiary centre, between January 2008 and December 2014. All patients under 18 years old with a unilateral BAHA were included in the study. RESULTS: A total of 53 children, with a BAHA, were included in the study. Post-operative skin complications were observed in 49.1% of the patients. Of the children, 28.3% presented with soft tissue hypertrophy, the most frequently reported skin complication, and grading according to the Holger's classification was not considered feasible. To overcome the difficulties we face in clinical practice, a new classification was developed and presented. CONCLUSION: The new proposed classification - Coutinho Classification - aims to fill the gaps in the one used currently by introducing new clinical features, most importantly the presence/absence of tissue overgrowth, and by providing a better description of what each category encompasses. This is an inclusive and objective new classification system, maintaining applicability, and useful in guiding the treatment.

Experience With the New Active Transcutaneous Bone-Conduction Implant With Smaller Dimensions.

OBJECTIVE: Recently, the Bonebridge 602 implant was introduced. Its smaller dimensions facilitate implantation even in surgically demanding cases. However, in extreme anatomical conditions, implant lifts are still required. We intended to report on the medical and audiological outcomes of all patients implanted with the implant with a secondary focus on the safety, efficacy, and feasibility of the use of 1-mm lifts. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic center. METHODS: We retrospectively analyzed all patients implanted with the Bonebridge 602. Patient demographics and surgically-specific data were collected from the medical charts. Furthermore, audiological results were assessed. Outcomes were compared between implantations with versus without lifts. RESULTS: Twenty-one devices were implanted during the study period. Satisfactory audiological results were observed, while no intra- or postoperative adverse events occurred. The majority of patients were daily users at the end of the observation period (n = 20/21, 95.2%), and one patient (n = 1/21, 4.8%) was a nonuser after 6 months of use because of subjective dissatisfaction. Due to anatomical considerations, 1-mm lifts were used in 4 implantations (19.0%). The application of lifts did not result in prolonged surgical times, complications, or shorter time of use, nor did it negatively affect audiometric results. CONCLUSION: Implantations with the new and smaller Bonebridge were associated with gratifying medical and audiological outcomes. Still, in extreme anatomical conditions, 1-mm lifts are necessary. Nonetheless, surgical placement with the help of lifts seems safe, effective, and feasible, and is a viable option in cases with challenging anatomies due to previous surgeries or anomalies.

Surgical results of transcutaneous bone-anchored hearing aid comparing the C-shaped and linear incision techniques.

PURPOSE: The aim of the study is to compare the operative time and postoperative complication outcomes for bone-anchored hearing aid (BAHA) implants using two different techniques: the C-shaped incision technique and the linear incision technique. METHODS: An analysis was carried out of 38 patients implanted with transcutaneous BAHAs during a 4-year period in a single otolaryngology department. RESULTS: The implantation was carried out under general anesthesia. Operative time was significant lower with the linear technique compared to the C-shaped technique (76.55 min, SD 16.75 vs. 93.17 min, SD 19.82; p = 0.007). There was no difference in postoperative complications between the two techniques. CONCLUSIONS: The use of linear incision for transcutaneous BAHA system implantation is associated with a reduced surgery time compared to the C-shaped technique, with no increase in postoperative complications.

Predictors of successful natural sleep MRI for sensorineural hearing loss in infants.

OBJECTIVES: Cochlear implantation (CI) in children with sensorineural hearing loss (SNHL) before 12 months of age (mo) improves language outcomes. MRI is important to assess CI candidacy. Anesthesia before 3 years old may increase risk of neurocognitive delay. Natural sleep MRI (NS-MRI) is an emerging technique to avoid anesthesia in infants, but relies on successful sleep for adequate imaging. Our multidisciplinary team hypothesized the following predictors of successful NS-MRI for CI evaluation: age, distance travelled, comorbidities, primary language, insurance type, HL characteristics, time and duration of MRI. METHODS: We performed retrospective review of children 0-12mo who attempted NS-MRI. The NS-MRI was successful if imaging was sufficient for definitive clinical management per the managing otolaryngologist. RESULTS: Among 26 patients (29 scans), the median age was 3.2mo (range: 1.2-6.8mo), distance travelled was 16.3 miles (range: 0.9 to 365 miles), 12 (46%) children had medical comorbidities. 8 (31%) had public insurance. 10 (38%) had bilateral HL. 52% (15/29) of scans were successful. Patients with comorbidities had significantly lower odds of successful NS-MRI (OR 0.09; 95% CI 0.01-0.54). Success was not associated with age, distance travelled, insurance type, primary language, HL characteristics, time or duration of MRI on univariable analysis. All 11 children who failed NS-MRI underwent hearing-aid fitting and/or imaging with sedation and CI as clinically indicated before 12mo. CONCLUSION: NS-MRI was successful in 52% of infants, regardless of age, demographics, HL or MRI characteristics. Unsuccessful NS-MRI did not result in delayed intervention. NS-MRI is an effective consideration for a broad range of infants with SNHL.

Outcomes After Transcutaneous Bone-Conduction Implantation in Adults and Children.

OBJECTIVE: To evaluate clinical and audiometric outcomes of adult and pediatric patients implanted with a semi-implantable transcutaneous active bone-conduction implant. STUDY DESIGN: Retrospective chart review. SETTING: Two tertiary referral centers. PATIENTS: Subjects implanted with the semi-implantable transcutaneous active bone-conduction implant called BoneBridge. INTERVENTION: Implantation of the BoneBridge and audiometric evaluations. MAIN OUTCOME MEASURES: Audiometric, clinical, and surgical outcomes as well as complications. RESULTS: Forty-two adults and 20 children were implanted for conductive or mixed hearing loss as well as single-sided deafness. Implantation significantly improved mean air-conduction pure-tone average from 72.8 ± 22.3 to 35 ± 9 dB in adults and from 65.7 ± 24.3 to 19.6 ± 8.2 dB in children (both p < 0.001). Word recognition score improved from 63.7 ± 38.8% to 85.6 ± 10.6% in adults and 57.8 ± 38% to 89.3 ± 10.1% in children (both p < 0.05). The rate of revision surgery was 11.3%, with four patients (6.5%) undergoing removal for device-related complications, two (3.2%) for complications associated with implantation, and one (1.6%) for device failure secondary to external trauma. CONCLUSIONS: In a large retrospective series consisting of both pediatric and adult patients, implantation with a transcutaneous active bone-conduction implant was found to be a reliable aural rehabilitation option for a variety of hearing loss etiologies.

Surgical Removal of Hearing Aid Earmold Impression Material in the Middle Ear.

When fitting hearing aids, patients are required to make an earmold impression material for device fixation. It usually causes no problems, although in rare cases, the earmold passes through the middle ear through tympanic membrane perforations.1-3 Foreign bodies may cause a delayed inflammatory reaction and deterioration of aeration, especially in the Eustachian tube. Herein, we report a rare case of earmold impression material as a foreign body in the middle ear that required surgical removal.

Long-Term Follow-up of a Wide-Diameter Bone-Anchored Hearing Implant: 10-Year Experience on Stability, Survival, and Tolerability of an Implant-Abutment Combination.

OBJECTIVE: To compare stability, survival, and soft tissue reactions between a wide-diameter (test) and previous-generation small-diameter (control) bone-anchored hearing implant and to ascertain the safety of loading the test implant 3 weeks after surgery, at a long-term follow-up of 10 years. STUDY DESIGN: This study is a continuation of two previously completed, multicenter, randomized, controlled trials and consisted of one to two additional follow-up visits until 10 years after surgery. PATIENTS: Fifty-one of the 72 participants from the previous trials were included. Patients received a test or control implant. All control implants were loaded 6 weeks after surgery (group A). Test implants were loaded 3 (group B) or 6 weeks (group C) after surgery. RESULTS: The test implant showed significantly higher implant stability quotient (ISQ) values than the control implant throughout the 10-year follow-up. At 10 years, the mean ISQ-high values for both implants were higher than at the first follow-up visit. No significant differences in change of ISQ-high from baseline to 10 years were noticed between both implants and loading groups. Soft tissue reactions were rarely seen. At 10-year follow-up, no patients presented with adverse soft tissue reactions. Excluding explantations, the implant survival rate was 78.6% (group A), 100% (group B), and 90.0% (group C). CONCLUSIONS: The test implant showed superior mean ISQ values and significantly better implant survival throughout 10-year follow-up. In addition, the current study concludes that it is safe to load the test implant at 3 weeks after surgery, as long-term results show high ISQ values and good implant survival.

Dementia and hearing-aid use: a two-way street.

OBJECTIVES: Hearing-aid use may reduce risk of dementia, but cognitive impairment makes use more challenging. An observed association between reduced hearing-aid use and incident dementia could reflect either or both of these causal paths. The objective was to examine the effects of each path while minimising contamination between paths. METHODS: Health records data from 380,794 Veterans who obtained hearing aids from the US Veterans Affairs healthcare system were analysed. Analysis 1 (n = 72,180) used multivariable logistic regression to model the likelihood of incident dementia 3.5-5 years post hearing-aid fitting for patients free of dementia and mild cognitive impairment (MCI). Analysis 2 (n = 272,748) modelled the likelihood of being a persistent hearing-aid user at 3 years 2 months after fitting, contrasting subgroups by level of cognitive function at the time of fitting. Analysis time windows were optimized relative to dataset constraints. Models were controlled for available relevant predictors. RESULTS: The adjusted OR for incident dementia was 0.73 (95% CI 0.66-0.81) for persistent (versus non-persistent) hearing-aid users. The adjusted OR for hearing-aid use persistence was 0.46 (95% CI 0.43-0.48) in those with pre-existing dementia (versus those remaining free of MCI and dementia). CONCLUSION: Substantial independent associations are observed in both directions, suggesting that hearing-aid use decreases risk of dementia and that better cognitive function predisposes towards persistent use. Research studying protective effects of hearing-aid use against dementia needs to account for cognitive status. Clinically, hearing devices and hearing care processes must be accessible and usable for all, regardless of their cognitive status.

Single-Center Experience Evaluating Clinical Outcomes of a Novel-Guided Drill System for Percutaneous Bone-Anchored Hearing Implant.

OBJECTIVE: Evaluate intraoperative and postoperative outcomes of a novel guided drill system for percutaneous bone-anchored hearing implants. METHODS: Between January 2016 and February 2021, patients age ≥18 years deemed potential candidates for a bone-anchored hearing device, were formally assessed for candidacy and counseling. Those that qualified and opted to proceed were added to a prospectively maintained database, including demographic, clinical, and audiologic data. Intraoperative findings were reported, as were clinical outcomes at 7 days, 4 weeks, 3 months and 6 months postoperatively. The Holgers index was used to grade soft tissue reactions. RESULTS: One hundred patients underwent the procedure. There were 56 women, and mean age was 54 years (18-84 yr). Ninety-six were done under local anesthetic. Mean surgical time was 13 minutes (9-27 min). No significant intraoperative events were noted. There were nine cases of implant loss, all in the first 50 cases. Mean duration of implant loss was 3.6 weeks (range, 2-5 wk). At the first postoperative visit, 82 had Holgers 0, 16 Holgers 1, 2 Holgers 2, and none Holgers 3. At the second postoperative visit, excluding the 9 with implant loss, 83 (91%) had Holgers 0, 6 (7%) Holgers 1, and 2 (2%) Holgers 2. None were Holgers 3. CONCLUSIONS: The current study represents, to our knowledge, the largest series on the novel guided drill technique. Results show it is safe and efficient with low soft tissue complication rates. Drill bit design and technical modifications may have helped lower implant loss rate in this series over time.

Efficient Bone Conduction Hearing Device With a Novel Piezoelectric Transducer Using Skin as an Electrode.

OBJECTIVE: Bone conduction hearing aids are the only non-surgical devices used for conductive hearing loss. However, they are impractical for lifelong use since they require close contact of the transducer with the head skin, causing skin erosion and discomfort. Bone conduction hearing implants and active middle ear implants do not present these issues; however, they require surgery and can sometimes cause issues in the skin surrounding the devices. This study aimed to develop a new bone conduction hearing device that does not exert pressure on the skin or require surgery. METHODS: Our device modified a piezoelectric element by using the skin of a pinna as one of the two electrodes of a conventional piezoelectric device. We compared the sound transmission of a speaker, a conventional piezoelectric device, or the new device to the Guinea pig cochlea, a physiological sound transducer to the auditory nerve, in normal and air-conductive hearing loss conditions. RESULTS: The novel device transmitted sound to the cochlea even after causing air-conductive hearing loss. Its bone conduction was more efficient than the speaker and the conventional piezoelectric device. CONCLUSION: We developed a novel type of bone conduction device that efficiently transmits sound to the cochlea by skipping the external auditory canal, tympanic membrane, and middle ear ossicles. This device does not exert pressure on the skin that can result in skin damage, an adverse effect of a conventional bone conduction hearing aid. SIGNIFICANCE: Our novel hearing device can be used as a substitute for current bone-conduction hearing devices.

Foreign Body Complications in Ears due to Mishandled Hearing Aid Fitting and Proposed Clinical Guidelines to Address the Complications.

BACKGROUND: South Korea has one of the world's fastest aging populations and is witnessing increased age-related hearing impairment cases as well as an increase in the number of hearing aid users. The aim of this study was to analyze complications caused by hearing aid mold materials. In addition, we hope to raise awareness of the harm and danger that inexperienced hearing aid providers can cause to patients. METHODS: We retrospectively reviewed the medical records of 11 patients who were diagnosed with hearing aid mold material as a foreign body in the ear at a tertiary center between 2016 and 2020. The following data were analyzed: symptoms, endoscopic findings, audiometry, temporal bone CT images, treatment methods, and complications after removal. The currently available literature was also reviewed to develop clinical guidelines, to identify the systematic weaknesses in the South Korean hearing aid market, and to identify policies that warrant better quality control. RESULTS: Among the 11 cases, 9 were restricted to the external auditory canal, all of which were successfully removed under endoscopy with minor complications. Two cases with middle ear involvement resulted in infection and thus required surgical removal with mastoidectomy. The average age of these patients was 76.4, and all patients received their molding procedure at private hearing aid shops without an otolaryngologist's examination. CONCLUSION: Thorough patient history-taking and otologic examination must be performed to identify patients at higher risk of complications. Such patients should be referred to an otolaryngologist. If a patient exhibits alarming symptoms, early referral is critical since prompt surgery can minimize complications. A CT scan is highly recommended to determine an optimal approach for foreign body removal. Systematic and regulatory changes in hearing aid dispensers, such as requiring apprenticeship, raising the required level of education, and legally mandating referrals, can help reduce these complications.

Clinical Evaluation of a Novel Laser-Ablated Titanium Implant System for Bone Anchored Hearing Systems in a Pediatric Population and the Relationship of Resonance Frequency Analysis With Implant Survival.

OBJECTIVE: To evaluate the clinical outcomes of pediatric patients implanted a novel 4.5 mm wide laser ablated titanium bone anchored implant system and to evaluate the implant stability over the first 12-month period. STUDY DESIGN: A prospective, single-subject, repeated measure, cohort study. Participants served as their own controls. SETTING: Community and tertiary referral hospital pediatric assessment center. PATIENTS: A total of 115 consecutive pediatric patients aged 4 to 15 years were implanted with 176 laser ablated titanium bone anchored implants from January 2016 to January 2019. MAIN OUTCOME MEASURE: Clinical outcomes, implant failure rates, and post implantation implant stability quotient (ISQ) scores were studied over the first 12-month period. Data were analyzed for statistical significance through mixed effect modeling, with the significance level p = 0.01. RESULTS: A median 12-month survival of 96.6% was observed. Six implants (3.5%) were lost in total, one of these (0.6%) was lost due to trauma. Adverse skin reactions (Holgers grade 2-4) were observed in 4.4% of all postoperative visits, occurring in 22 individuals (19.1%). Neither the ISQ high (ISQH) nor ISQ low (ISQL) values increased significantly between the stage 1 and 2 surgeries. In contrast, the ISQ results, irrespective of abutment size, demonstrated an increasing trend from 49.1 to 57 over the 12 months review period. A statistically significant change was only demonstrated from the 3 months follow up onwards. CONCLUSION: The use of 4.5 mm wide laser-ablated titanium bone anchored hearing implants resulted in superior survival rates and excellent clinical outcomes compared with previous implant systems.

Novel Surgical Technique in Active Bone Conduction: Minimally Invasive Approach to Fully Implantable Osseointegrated Implant.

We report our experience using a novel minimally invasive surgical technique for implantation of a fully implantable active bone conduction implant. This was a retrospective review of 16 adults, including 10 women and 6 men. The mean age was 54 years. Hearing loss profiles included 8 with mixed hearing loss, 5 with conductive hearing loss, and 3 with single-sided deafness. Nine patients underwent placement through the standard approach and 7 with the minimally invasive approach. There were no postoperative complications at a mean follow-up of 6.5 months (SD, 4; range, 1.5-12), and all patients received audiologic benefit with objective improvement in sound-field thresholds upon activation. Mean operative time was shorter with the minimally invasive approach (64 vs 41 minutes, P = .01). The fully implantable bone-anchored auditory implant can be effectively placed via a minimally invasive incision, with potential benefits of decreased operative time, low risk for intra- and postoperative complications, and rapid healing.

Safety and Efficacy of Implantation of the Bonebridge Active Transcutaneous Bone-Conduction Device Using Implant Lifts.

BACKGROUND: Implant lifts were recently introduced to facilitate implantation of the Bonebridge and to reduce the risk of uncovering the sigmoid sinus and/or dura. PURPOSE: The current study analyzed medical, technical, and audiological outcomes of implantation with the Bonebridge implant using lifts. RESEARCH DESIGN: This was a retrospective study on all consecutive patients implanted with a bone-conduction hearing implant at a tertiary medical referral center between March 2012 and October 2018. Outcome measures were complications, explantations, and revisions and the mean time of implant use. Audiological results were assessed as well. Outcomes were evaluated for devices implanted with BCI Lifts and compared with those implanted without lifts. RESULTS: In the study period, 13 out of a total of 54 implantations were conducted using one or two 1- to 4-mm BCI Lifts. During the follow-up period, two complications occurred and both in patients implanted without lifts (2/41; 4.9%). All patients in the lifts group were using the implant at the end of observation period. No statistically significant difference was observed in functional hearing gain or word-recognition improvement at 65 dB between two groups. CONCLUSIONS: The use of BCI Lifts in Bonebridge implantations was not associated with adverse events during the observation period. The clinical follow-up revealed no complications in implantations requiring lifts. Furthermore, the functional hearing gain and the word-recognition improvement did not differ from those of devices implanted without lifts. Data indicate safety and efficacy for Bonebridge implantations using lifts.